Creep test for packaging

The creep test determines package strength by pressurizing a package at 80% of the known burst pressure for a set amount of time.  This test method is defined in ASTM F1140 and conforms to ISO 11607 "Packaging for terminally sterilized medical devices."

Study Outline

Porous packages are prepared by placing tape over the porous surface to reduce the rate which air escapes.  The set up packages are used to set the machine to 80% of the lowest burst pressure as determined from a previous burst test.  A probe is inserted into the sample package and the machine started.  The package inflates to the set pressure and the timer starts.  The test continues until the package bursts (failure) or the set time is reached.  The machine records the pressure for each sample.  Any failures are reported with time to failure and failure location.

Sample Requirements

Minimum sample size: complete packages
Recommended replicates: The number of test packages that are needed for this test are at the discretion of the sponsor. However, Nelson Labs recommends that at least 11 test packages be tested to make sure that the test is statistically significant.

Minimum per product type/lot: 11 samples + 3-5 set-up samples

Nelson Experts:

• Jennifer Gygi 801-290-7847, 800-826-2088

Sample Requirements

Minimum sample size: complete packages
Recommended replicates: The number of test packages that are needed for this test are at the discretion of the sponsor. However, Nelson Labs recommends that at least 11 test packages be tested to make sure that the test is statistically significant.

Minimum per product type/lot: 11 samples + 3-5 set-up samples